Do not use Testim Gel:

• if you have or are suspected of having prostate cancer
• if you have or are suspected of having male breast cancer (a rare condition for men)
• if you are allergic to testosterone or soy or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before using Testim Gel

• if you have difficulty in passing water (urinating) due to an enlarged prostate gland
• if you are suffering from severe heart, liver or kidney disease, treatment with Testim GEL may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
• if you have high calcium levels in your blood or urine caused by bone cancer you may be advised by your doctor to undergo regular blood tests
• if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure.
• if you suffer from ischaemic heart disease (a condition that affects the supply of blood to the heart)
• if you have epilepsy
• if you suffer from migraines
• if you have breathing difficulties during sleep; these are more likely to occur if you are overweight or have chronic lung disease.
• if you have or have ever had blood clotting problems; thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels)
• factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
• How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.

These conditions may be aggravated when using Testim Gel. If you have any of the above conditions go back to your doctor to seek advice.

If you develop serious reactions on your skin where you applied the Testim Gel, go back to your doctor to seek advice.

If you have close skin-to-skin contact, testosterone may be transferred to someone else. For further information, please refer to section 3 (How to use).

The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. Testosterone treatment may accelerate the progression of pre-existing prostate cancer. Your doctor will perform the necessary tests before starting treatment and then check by carrying out periodic blood tests and prostate examinations.

If you are an athlete, be aware that this product may produce a positive reaction in anti-doping tests.

Testosterone must not be used to increase muscles or improve physical strength in healthy individuals.

Children

TESTIM is not indicated in children.

Other medicines and Testim Gel

Tell your doctor if you are using, have recently used or might use any other medicines.

TestimGel may affect how these medicines work and you may need to have your doses adjusted. This is particularly important if you are taking:

• insulin to control your blood sugar levels (in diabetes): you may need to reduce your dose of insulin when using in combination with Testim Gel
• drugs to thin your blood (anti-coagulants): Testim Gel may increase the effects of these drugs
• corticosteroids or drugs which may increase the production of these hormones (ACTH): both corticosteroids and Testim Gel may cause your body to retain more water.

Other forms of interactions: laboratory test interactions. Treatment with testosterone may alter the levels of thyroid hormones in your body. The thyroid function is not affected by these minor changes in levels of thyroid hormones. The thyroid is a gland located in the neck and is involved in the regulation of the body’s metabolism and growth.

Pregnancy and breast-feeding

Testim Gel is not intended for use by women.

Pregnant women should avoid skin contact with Testim Gel application sites in men as testosterone can cause the appearance of male secondary sex characteristics in the female foetus.

Breast-feeding women should also avoid any contact with Testim Gel application sites in men.

If your partner is or becomes pregnant, you must follow the advice under the heading ‘How to prevent transfer of Testim Gel to someone else’ on the other side of this leaflet

Testim Gel contains propylene glycol

This product contains propylene glycol which may irritate your skin.